Travel Vaccine Breaking News

Travel vaccine breaking news brought to you by Vax Before Travel.

Jul 20, 2023 • 4:22 pm CDT
U.S> CDC influenza vaccination trends 2023

The journal Vaccines recently published the results from a study led by University of Pittsburgh scientists that found both recombinant influenza vaccine (RIV4) and standard-dose influenza vaccine (SD-IIV4) effectively prevent influenza hospitalization.

Of the 14,590 individuals included in the primary analysis, the overall RIV4 relative vaccine effectiveness (rVE) was significant when adjusted for propensity scores with inverse probability weights (rVE = 31; 95 % CI = 11 %, 46 %).

Among younger adults (18–64 years-old), overall rVE of RIV4 was significant (rVE = 29; 95 % CI = 4 %, 47 %).

These scientists wrote, "Both RIV4 and SD-IIV4 were significantly effective among all adults against influenza-related hospitalizations during the 2018–2019 and 2019–2020 influenza seasons."

"Relative vaccine effectiveness of RIV4 compared with SD-IIV4 was significant for all adults and younger and healthier recipients."

On June 27, 2023, the CDC Director adopted the 2023-2024 Advisory Committee on Immunization Practices’ recommendations on annual influenza vaccination for everyone six months and older in the United States.

The CDC's recommended timing of flu vaccination has not changed.

September and October are the best times for most people to get vaccinated. Flu vaccination in July and August 2023 is not recommended for most people.

Disclosures: The University of Pittsburgh Institutional Review Board approved this retrospective study using EMR databases. Drs. Zimmerman, Raviotta, Nowalk, and Balasubramani received investigator-initiated grant funding from Sanofi for this project. Drs. Nowalk and Balasubramani have grant funding from Merck & Co., Inc. for an unrelated project. 

Jul 20, 2023 • 3:33 pm CDT
From Pixabay

The U.S. Department of State recently reissued its Level 2: Exercise Increased Caution notice for the Commonwealth of The Bahamas.

As of July 17, 2023, the State Department confirmed that most crime occurs on New Providence (Nassau) and Grand Bahama (Freeport) islands.

In Nassau, practice increased vigilance in the “Over the Hill” area (south of Shirley Street).

Violent crimes, such as burglaries, armed robberies, and sexual assaults, occur in tourist and non-tourist areas. And be vigilant when staying at short-term vacation rental properties where private security companies do not have a presence. 

Additionally, vacation activities involving commercial, recreational watercraft, including water tours, are not consistently regulated.

As of July 1, 2023, U.S. Embassy Nassau issued form DS-2060, U.S. Department of State Report of Death of a U.S. Citizen or U.S. Non-Citizen National Abroad.

Due to these concerns, U.S. government personnel cannot use independently operated jet-ski rentals on New Providence and Paradise Islands. 

If you travel to The Bahamas, the State Department advises enrolling in the Smart Traveler Program to make it easier to locate you in an emergency.  

Should Americans need local assistance, the U.S. Embassy Nassau is located at #42 Queen Street.

From a health perspective, the U.S. CDC says to check your travel vaccines and medicines list and visit a healthcare provider at least a month before your trip to The Bahamas in 2023.

Jul 20, 2023 • 2:27 pm CDT
WHO COVID-19 case report July 20, 2023

The World Health Organization (WHO) today published its Weekly Epidemiological Update on COVID-19 Edition #152, which stated during this recent 28-day period, 56% (131 of 234) of countries and territories reported at least one case.

As of July 20, 2023, the WHO reported that while five WHO regions confirmed decreases in COVID-19 cases and deaths, the Western Pacific Region has reported a decline in cases but an increase in fatalities.

At the country level, the highest numbers of new 28-day cases were reported from the Republic of Korea (372 557 new cases; -22%), Australia (62 748 new cases; -59%), Brazil (56 744 new cases; -50%), New Zealand (38 949 new cases; +12%), and Singapore (28 333 new cases; -59%).

From a prevention perspective, about 12 COVID-19 vaccines and monoclonal antibody therapies are in use globally.

Jul 20, 2023 • 1:55 pm CDT
Africa CDC July 2023

The Africa Centres for Disease Control and Prevention (Africa CDC), the World Health Organization, and the Robert Koch Institute today announced a Health Security Partnership focused on strengthening disease surveillance and epidemic intelligence in Africa.

Substantial progress has been made in disease surveillance across Africa over the past decade, but it is worth noting that it experiences more outbreaks and other health emergencies than others, many of which are preventable or controllable with proven public health interventions, wrote the Africa CDC on July 18, 2023.

“Our collective ability to prevent, prepare for, and respond to healthy security emergencies remains critical to keeping our communities safe,” said Sara Hersey, Director of Collaborative Intelligence at the WHO Hub for Pandemic and Epidemic Intelligence, in a press release.

“Through this partnership, WHO remains dedicated to working with Member States to systematically strengthen our capabilities and collaboration across stakeholders, sectors, and borders for more effective and collaborative disease surveillance in Africa.”

Jul 20, 2023 • 10:58 am CDT
by Vitor Vitinho

Pfizer Inc. today announced data from a Phase 2 clinical study investigating its hexavalent capsular polysaccharide (CPS) conjugate Group B Streptococcus (GBS) vaccine candidate, GBS6.

This vaccine candidate is being developed for maternal administration to protect infants against invasive GBS disease.

In stage two of the three-part study, GBS6 generated robust maternal antibody responses against the six GBS CPS serotypes included in the vaccine, and these antibodies were efficiently transferred to infants at ratios of ~0.4-1.3 depending on the GBS6 group.

Based on a parallel natural history study conducted in South Africa, the Phase 2 study immunogenicity data suggest that GBS6 may offer meaningful protection against invasive GBS disease in newborns and young infants.

The results were published in an Original Article in The New England Journal of Medicine on July 20, 2023, and will inform a planned Phase 3 clinical development program.

“Group B Streptococcus can cause potentially devastating diseases in infants, including sepsis, pneumonia, and meningitis. Annually, there are nearly 400,000 cases of infant disease and approximately 138,000 stillbirths and infant deaths worldwide due to GBS,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a press release on July 19, 2023.

“Building on decades of expertise and knowledge in vaccines, we are committed to helping protect newborns and young infants through maternal immunization.”

The U.S. CDC says bacteria called group B Streptococcus cause GBS disease.

GBS bacteria commonly live in people’s gastrointestinal and genital tracts. The genital tract is the part of the body involved in reproduction and includes the vagina in women.

Sometimes the bacteria invade the body and cause certain infections, which are known as GBS disease.

Jul 20, 2023 • 10:33 am CDT
Texas Dept of Health July 2023

The Texas Department of State Health Services (DHSHS) today announced that no-cost health clinics will be available for residents of South Texas next week.

Operation Border Health Preparedness (OBHP) will operate in the Rio Grand Valley from July 24-28, 2023.

OBHP services will include immunizations for children and adults, medical exams, student sports physicals, health and diabetes screenings, dental and vision exams, and prescription glasses from a mobile lab. 

In 2022, OBHP provided 30,031 health services to about 6,400 patients.

“Operation Border Health Preparedness allows DSHS and its partners to develop and refine their emergency response actions while also providing no-cost healthcare options for many South Texas residents who may face challenges receiving health care,” said DSHS Commissioner Jennifer Shuford, MD, MPH, in a media statement on July 20, 2023. 

“For some (Texas) residents, this may be their only time to visit with a doctor this year.”

Services vary by location, so the public can visit dshs.texas.gov/obhp2023 or call 2-1-1 to confirm which services are offered at a specific Texas location.

Jul 20, 2023 • 9:51 am CDT
by Arek Socha

Vir Biotechnology, Inc. today announced that the Phase 2 clinical trial (PENINSULA) evaluating VIR-2482 for preventing symptomatic influenza A illness did not meet primary or secondary efficacy endpoints.

In participants who received the highest dose of the investigational hemagglutinin-targeting monoclonal antibody (mAb) VIR-2482 (1,200 mg), a non-statistically significant reduction of approximately 16% in influenza A protocol-defined illness was observed.

And participants who received the highest dose showed an approximately 57% reduction in symptomatic influenza A illness when defined according to U.S. CDC influenza-like-illness criteria, which was one of two secondary endpoints.

VIR-2482 was generally well tolerated, and no safety signals were identified.

“We are grateful to all who participated in this trial, and we remain committed to the pursuit of novel therapies that have the potential to address some of the world’s most serious infectious diseases,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer, in a press release issued on July 2023.

The PENINSULA trial has been supported in whole or in part with federal funds from the Department of Health and Human Services, the Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority.

As of July 20, 2023, about 95 million influenza vaccines were being distributed in the U.S. The U.S. CDC recommends an annual flu shot for most people, which is offered at most health clinics and community pharmacies in the U.S.

Jul 19, 2023 • 3:40 pm CDT
by Andros from Pixabay

The Lancet Global Health published an early-release study funded by Unitaid that estimated preventive tuberculosis (TB) treatments offered to people with HIV/AIDS (PLWHA) and household contacts of newly diagnosed TB patients could save nearly 850,000 lives by 2035.

People living in close contact with a person with TB disease are at highest risk of infection, accounting for a significant percentage of the 10.6 million new TB infections yearly.

These researchers wrote on July 18, 2023, that the costs of scaling up a TB preventive treatment (TPT) program, including TPT drugs and investigation to rule out active disease, are a major barrier to implementing TPT guidelines and allocating resources.

This study found implementing short-course TPT is likely cost-effective for people living with HIV/AIDS, including child and adult contacts in most countries. 

Between 2023 and 2035, scaling up TPT prevented 0.9 (95% uncertainty interval) people from developing TB and 0.13 (0·05–0·27) TB deaths per 100 PLWHA at an incremental cost of $15 per PLWHA.

“The imperative for TB prevention is clear,” said Vincent Bretin, Director of Results at Unitaid, in a related press release.

“This cost-effectiveness analysis proves that preemptively reaching all at-risk individuals – even when it requires the logistical hurdles of going into communities to find those who may not be actively seeking care – is not just ethically sound. It is a smart investment capable of making an enormous impact on the fight to end TB worldwide.”

Previous studies found deploying the 100-year-old BCG vaccine with children offered ample protection against TB and would save billions in healthcare costs.

As of July 2023, over 14 types of BCG vaccines are in use globally. In the U.S., the BCG vaccine is considered for people who meet specific criteria.

Jul 19, 2023 • 2:28 pm CDT
Dengue in the Americas may July 2023

Since the beginning of 2023, dengue outbreaks of significant magnitude have been recorded in the WHO Region of the Americas, with close to three million suspected and confirmed cases of dengue reported as of July 19, 2023.

This total surpassed the 2.8 million cases of dengue registered for the entire year of 2022.

The WHO has assessed the risk of dengue as high at the regional level since all four dengue virus serotypes are present in the Region of the Americas.

One example of these dengue outbreaks is Costa Rica.

As of EW #25, there have been 2,712 reported dengue cases, which is 16% higher compared to the same period in 2022 and 19% higher compared to the average of the last five years.

Almost half of the world’s population, about 4 billion people, live in areas with a risk of dengue. Dengue is often a leading cause of illness in areas with risk, says the U.S. CDC.

In the U.S., Florida continues to report both locally-acquired and travel-related dengue cases in July 2023.

Symptoms can be mild or severe for people who get sick with dengue. However, severe dengue can be life-threatening within a few hours and often requires care at a hospital.

Dengue viruses are spread to people through the bite of an infected Aedes mosquito.

The WHO does not recommend travel restrictions for countries in the Americas experiencing dengue epidemics based on the currently available information.

From a disease prevention perspective, two approved dengue vaccines (Qdenga and Dengvaxia) are available in certain countries in 2023.

Jul 19, 2023 • 9:48 am CDT
by Neil Dodhia

VBI Vaccines Inc. today announced that the PreHevbri® vaccine is now available in the Netherlands and Belgium for active immunization against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults.

It is the only approved 3-antigen hepatitis B vaccine for adults in the Netherlands and Belgium.

As part of the partnership announced in September 2022, PreHevbri is available through France-based Valneva SE's commercial infrastructure and distribution networks.

PreHevbri (PreHevbrio™, Sci-B-Vac®) can be expected that hepatitis D will also be prevented by immunization with PreHevbri as hepatitis D does not occur without hepatitis B infection.

Jeff Baxter, President and CEO of VBI, commented in a press release on July 19, 2023, "Over the next several months, we expect to continue to expand global access to PreHevbri with additional market launches as we work to make an impact in the fight against hepatitis B worldwide."

This HBV vaccine is currently available in the U.S., Europe, the U.K., and Israel. 

Hepatitis B is one of the world's most significant infectious disease threats, with more than 290 million people infected globally. It is the leading cause of liver disease, about 25%, and is tough to cure, says the U.S. CDC.

Furthermore, women with hepatitis B can transmit the virus to their newborns during birth. If not vaccinated, 90% of infants infected with HBV at birth will progress to chronic HBV infections.

Jul 19, 2023 • 9:27 am CDT
Emergex’s vaccines July 2023

Emergex Vaccines Holding Limited today announced the successful completion of naNO-COVID, a Phase I clinical trial investigating the safety and reactogenicity of CoronaTcP™ in healthy volunteers. 

CoronaTcP is Emergex's multi-target T cell-priming set-point product, designed to be broadly effective against diseases caused by betacoronaviruses, including SARS-CoV-1 and SARS-CoV-2 variants.

Cellular analyses demonstrated that CoronaTcP (two doses administered at Day 0 and 21) was able to activate virus-specific CD8+ T cells, with a significant increase in frequencies of CoronaTcP-specific CD8+ CD137+ CD69+ cells following in vitro antigenic stimulation in both low and high dose CoronaTcP groups at Day 35 post-treatment.

Significant changes were also observed for several virus-specific CD8+ memory subsets. 

Professor Thomas Rademacher, Co-Founder and Chief Executive Officer of Emergex, said in a press release on July 19, 2023, Demonstrating that our platform has an acceptable safety profile and successfully mobilizes specific T cells that may elicit broad and long-term immune memory, validates our approach."

"By improving T cell-based immunity, we can enhance any previous immune status. We are delighted that this first assessment of treatment against infectious diseases for clinical use, based solely on a T cell response, was successful."

Overall, Phase I trial data validate Emergex's T cell-based approach to protection against RNA viruses and confirm the platform's potential using this innovative technology, supporting the investigation of other T cell-priming immune set-point candidates from the same platform.

In secondary immunogenicity analyses, several participants seroconverted during the trial (due to exposure to SARS-CoV-2) but had mild symptoms, confirming that CoronaTcP does not worsen an acute episode of COVID-19.

The naNO-COVID trial was a Phase I double-blind, randomized, base particle-controlled, single-center study designed to evaluate the safety and reactogenicity of two intradermal injections of an anti-Betacoronavirus candidate.

Jul 18, 2023 • 4:27 pm CDT
by Emilian Danaila

The U.S. Centers for Disease Control and Prevention (CDC) today announced an Emergency Preparedness and Response COCA Call on July 20, 2023, where participants will learn how to prevent, diagnose, and treat malaria.

And how the biology of the pathogen contributes to the clinical management of the disease,

And how CDC and state and local health departments respond to the locally acquired mosquito-borne malaria cases in Florida and Texas.

Previously, the CDC issued a Health Alert Network Health Advisory on June 26, 2023, to share information on the recent identification of locally acquired, mosquito-transmitted malaria cases (P. vivax) in Florida and Texas.

Although these are the first documented instances of locally transmitted malaria in the U.S. since 2003, approximately 2,000 malaria cases are diagnosed and treated in the U.S. each year.

Malaria cases are primarily confirmed in individuals returning from travel to malaria-endemic countries such as Brazil and Cuba.

These malaria infections present a potential risk of subsequent transmission domestically since  Anopheles mosquitoes, capable of transmitting malaria, are broadly distributed across the United States.

For example, locally-infected and travel-related malaria cases in Florida were confirmed in July 2023.

During this COCA call on July 20, 2023, at 2:00 PM – 3:00 PM ET, at Webinar Link:  https://www.zoomgov.com/j/1618112526, will learn CDC and state and local health departments are responding to the locally acquired mosquito-borne malaria cases in the U.S.

Unfortunately, the U.S. government has not approved a malaria-prevention vaccine as of July 18, 2023.

Jul 18, 2023 • 3:17 pm CDT
Florida Health disease map July 2023

Florida Health's latest Mosquito-Borne Disease Surveillance report indicates the recent malaria outbreak in the Sarasota area has continued into the summer of 2023.

As of July 15, 2023, Florida Health'w week #28 reported confirmed the seventh locally-acquired malaria case in the Sarasota area since May 2023. The Plasmodium species reported were Plasmodium vivax.

And state-wide, there have been 26 travel-related malaria cases reported in Broward (5), Duval, Hillsborough (4), Lee, Leon (2), Miami-Dade (5), Orange (2), Osceola, Pinellas (3), Sarasota, and Volusia counties this year.

The majority of travel-associated malaria cases in Florida were in people who had recently visited Africa.

Malaria still threatens international travelers, military personnel, and U.S. citizens living and working abroad, says the Centers for Disease Control and Prevention (CDC).

According to the World Health Organization World Malaria Report, the global number of malaria outbreaks reached about 240 million cases, with over 600,000 related fatalities in 2021. 

As of July 18, 2023, the U.S. CDC says the bite of an infective female Anopheles mosquito spreads malaria.

The disease can cause fever, chills, and flu-like illness. If it is not treated, it can cause severe complications and death.

The CDC has issued malaria alerts for malaria-endemic countries, including Costa Rica, but not Florida.

Various antimalarial treatments are approved by the CDC in 2023, but not no malaria vaccines.

As of July 5, 2023, twelve African countries are set to receive 18 million doses of GSK's Mosquirix recombinant vaccine over the next two years. 

Jul 18, 2023 • 9:56 am CDT
by Gerd Altmann

Pfizer Inc. and Flagship Pioneering, Inc. today announced a partnership to create a new pipeline of innovative medicines. The focus will be addressing unmet needs within Pfizer's core strategic areas of interest, including in broad patient populations and diseases with high potential to benefit from diverse technology platforms and modalities.

Pfizer will fund and have options to acquire development programs.

Under the terms of the novel agreement, Flagship and Pfizer will each invest $50M upfront to explore opportunities to develop ten single-asset programs by leveraging Flagship's ecosystem of more than 40 human health companies and multiple biotechnology platforms.

To date, Flagship has deployed over $3.4 billion in capital toward the founding and growth of its pioneering companies alongside more than $26 billion of follow-on investments from other institutions.

Per the new agreement, Flagship and its bioplatform companies can receive up to $700M in milestones and royalties for each successfully commercialized program.

"At Pfizer, we are expanding our efforts to pursue potential breakthrough science with unique approaches and funding mechanisms designed to leverage the dynamic scientific ecosystem," said Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer, in a press release on July 18, 2023.

"This collaboration is an exciting opportunity for Pfizer to bring deep scientific expertise and apply our development and regulatory strength to Flagship's diverse portfolio of technology platforms, translating early-stage innovation to potential medicines."

Jul 18, 2023 • 4:58 am CDT
by Engin Akyurt

Vaxxinity, Inc. today announced new data from an early-stage clinical trial demonstrating that antibodies derived from its investigational immunotherapeutic for Parkinson's disease, UB-312, slows the seeding of alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) of patients as demonstrated using multiple target engagement assays.

These data signify that UB-312 has established clear target engagement in Parkinson's disease (PD) patient CSF.

Jean-Cosme Dodart, Ph.D., SVP of Research at Vaxxinity, commented in an email, “The more data we see from our UB-312 program, the more excited I get for the future of this vaccine and its potential positive impacts for patients with PD or other a-synucleopathies."

"Demonstrating target engagement in PD patients immunized with UB-312 is an exciting milestone which encourages us to push this program further into clinical development.”

UB-312 is a UBITh®-enhanced synthetic peptide-based vaccine designed to target aggregated forms of aSyn, the toxic species that underlies PD and other synucleinopathies.

"Our candidate has shown target engagement of the toxic species of alpha-synuclein in patients, demonstrating not only proof of our technology platform but also proof of the mechanism of our vaccine-derived antibodies specifically engaging with the toxic target in vivo," said Mei Mei Hu, CEO of Vaxxinity, in a press release on July 17, 2023.

"Showing target engagement has always been a key challenge to overcome in neurodegeneration and is of critical importance when demonstrated – a milestone worth celebrating."

"It is beyond our expectation to see this in our Phase 1 clinical trial."

"We are endlessly grateful to the patients who participated and to The Michael J. Fox Foundation and our collaborators for their work on these cutting-edge assays that supported this breakthrough."

Last month, Vaxxinity announced clinical data from Part B of its Phase 1 clinical trial of UB-312 demonstrating that UB-312 was well-tolerated and induced anti-aSyn antibody responses in participants with early PD and that antibodies were detectable in the CSF.

As part of this trial, The Michael J. Fox Foundation (MJFF) funded a 2-year collaborative project between Vaxxinity, the Mayo Clinic, and UTHealth Houston to analyze CSF collected from patients and to conduct exploratory research to characterize the anti-aSyn antibodies produced after UB-312 administration and assess target engagement.

Mark Frasier, Ph.D., Chief Scientific Officer of MJFF, commented, "Integration of critical biomarker insight into therapeutic development programs is essential for building confidence in the treatment approach and designing informative trials. We're pleased to support efforts of this kind that can have a major impact for people with Parkinson's disease."